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Arvis ® In-21904

by Kico Knee Innovation Company Pty Limited

Arvis ® In-21904 is a Class II device made by Kico Knee Innovation Company Pty Limited, cleared under FDA 510(k) K243980 on 21 Mar 2025 and listed in FDA GUDID since 17 Nov 2025 (UDI-DI 00850012315995), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K243980; other models may be affected

Documents

510(k) K243980

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850012315995 UDI-DI Date17 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK243980 Date21 Mar 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243980 decided 21 Mar 2025 Active
  • FDA GUDID UDI-DI 00850012315995 listed 17 Nov 2025 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2957-2026 FDA Class II initiated 13 Jul 2026 on shared 510(k) K243980

    Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K243980
  2. Listed FDA GUDID 00850012315995
  3. Recall initiated FDA recalls Z-2957-2026

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Arvis ®
Generic name
Orthopaedic stereotactic surgery system
Model / reference
IN-21904
Primary DI / UDI-DI
00850012315995
510(k) Number
FDA product code
OLO
GMDN term
Orthopaedic stereotactic surgery system
Device class
Class II
Regulation number
882.4560
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K243980)

and 8 more cleared under K243980

Other devices from Kico Knee Innovation Company Pty Limited

See all devices from Kico Knee Innovation Company Pty Limited →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)